đź“Š Evidence-Based Reference
durasheath introducer sheath system
Contract Medical International
Summary: The Durasheath Introducer Sheath System is a medical device used primarily for vascular access in embolization procedures. Key evidence highlights its role in facilitating minimally invasive interventions.
FDA Clearance Information
Pathway
510K
Number
K142357 ↗
Decision Date
June 25, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Durasheath Introducer Sheath System was cleared via the FDA 510(k) pathway on June 25, 2015. It is manufactured by Contract Medical International and is classified as a Class 2 device.
What It Is
The Durasheath Introducer Sheath System is designed to provide vascular access for the delivery of embolization coils. It facilitates the introduction of devices into the vascular system, ensuring a stable and secure pathway.
Clinical Applications
Commonly used in embolization procedures, the Durasheath Introducer Sheath System is applied in scenarios requiring precise vascular access, such as in the treatment of aneurysms or arteriovenous malformations.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, spanning from 2024 to 2025.
Reported Outcomes
Published studies report that the Durasheath Introducer Sheath System is effective in providing reliable vascular access for embolization procedures. It has been associated with improved procedural efficiency and patient outcomes in minimally invasive interventions.
Safety Profile
Reported complications include potential flow impedance when additional devices are introduced through the sheath. However, overall safety profiles in the studies reviewed indicate a low incidence of adverse events.
Evidence Limitations
The current evidence is limited by the small sample sizes and the short duration of follow-up in some studies. Further research is needed to establish long-term outcomes and to explore the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Durasheath Introducer Sheath System?
The device is indicated for use in embolization procedures requiring vascular access, such as treating aneurysms and arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies have reported effective vascular access and improved procedural efficiency with the use of the Durasheath Introducer Sheath System.
What complications have been reported?
Safety data indicate potential flow impedance when additional devices are used, but overall adverse events are low.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.